Valved body-fluid sampling tubes



May 4, 1965 E- H. WILBURN VALVED BODY-FLUID SAMPLING TUBES 4Sheets-Sheet 1 Filed July 30, 1962 E. H. WILBURN 4 Sheets-Sheet 2 VALVEDBODY-FLUID SAMPLING TUBES V I u May 4, 1965 Filed July 30, 1962 y 1965E. H. WILBURN 3,181,529

VALVED BODY-FLUID SAMPLING TUBES Filed July so. 1962 4 Sheets-Sheet aUnited States Patent 0 3,181,529 VALVED EQDY-FLUID SAlWlLlNG TUBES EdgarH. Wilbur-n, Rutherford, NJ. (Box 166, Highland Lakes, NJ.) Filed July30, 1962, Ser. No. 213,487 6 Claims. (Cl. 1282) The present inventionrelates to suction containers for taking samples of body fluids, such asblood, and is an improvement upon the plastic sampling tubes of the typedisclosed in the United States Lockhart Patent No. 2,727,- 516 ofDecember 20, 1955, for Medical Sampling Devices and Specimen Containers,as well as upon blood sampling evacuated glass tubes of conventionalconstruction some of which are marketed as Vacutainers.

It has been recognized that it is desirable that manipulations of suchdevices by an operator, such as a doctor or nurse, preparatory to takingsamples of body fluids therewith, be simplified. This is particularlytrue with respect to the identified plastic tube type which requirecollapsing of the tube (which may involve folding it) to expel thesterilized air from its chamber for converting the latter to a suctionchamber upon release of the tube. If the collapsed tube must be heldcollapsed or folded to maintain its chamber evacuated until its inlet orsuction passage is equipped with a sampling needle and then the latteris thrust to communication of a patients vein or fluid pocket in hisbody, or while the sampling tube is connected by the operator to such aneedle which has remained in the patients flesh in communication with avein or such pocket, these required manipulations may be difficult orannoying to either the operator or the patient as well as dangerous.Thus, while for various reasons familiar to those who take such samplesthe collapsible plastic sampling tubes may be desired as offeringcertain advantages over previously evacuated and sealed glass samplingtubes, many hospitals and operators prefer the latter because they makethe taking of the samples a simpler procedure. The present inventiondeveloped from a realization that the sampling procedure with suchplastic sampling tubes could be simplified by equipping the tubes withclosures having manipulative valves.

Many problems were encountered in the development of suitable valvingstructure and equipping such plastic tubes therewith. Leakage of air tothe suction chamber in all positions of the valve had to be avoided.Also, the valveequipped sampling tube had to be adapted to prevailingpractices in the treatment and care of patients and the taking of one orsuccessive samples of body fluids, such as blood, from them which mayrequire association with or connection to equipment designed for otherpurposes, such as intravenous feeding or blood donor sets. Avoidance ofcontamination of withdrawn samples had to be assured to the completesatisfaction of all concerned. And the structure had to be versatile forready adaptation to various habits of operators and differingrequirements of hospitals and doctors. These and other problems aresolved in efficient and acceptable manners by devices of the presentinvention.

Another object of the present invention is to provide various forms ofthe valved closures of the evacuated sampling tubes which embodyfluid-tight sealing means effective in all mounted positions of thevalves effectively to isolate the suction chambers from the ambientatmosphere.

A further object of the invention is to provide valving closures informs readily mountable to such collapsible plastic or rigid evacuatedtubes when each is provided with an open end equipped in a ready mannerwith simple closure engaging means.

Still another object of the invention is to provide forms of the devicewhich permit ready addition thereto of easily manipulative andprotective supplemental external valving means.

An additional object of the invention is the provision of embodimentswhich permit ready communication to their suction chambers of samplingtubing by means of cannulas either connectable to the manipulativevalves thereof or by thrust through the valved closures.

A still further object of the invention is to provide structuralembodiments which are readily constructed and permit efiicient use andoperation.

Other objects of the invention will in part be obvious and will in partappear hereinafter.

The invention accordingly comprises the features of construction,combinations of elements, and arrangement of parts, which will beexemplified in the constructions hereinafter set forth, and the scope ofthe invention will be indicated in the claims.

For a fuller understanding of the nature and objects of the inventionreference should be had to the following detailed description taken inconnection with the accompanying drawings, in which:

FIG. 1 is an exploded side elevational view, with parts broken away andin section, of an embodiment of the valved body-fluid sampling tube ofthe present invention, to about normal scale;

FIG. 2 is an enlarged axial section of the valved closureequipped end ofthe sampling tube shown in FIG. 1, with parts broken away;

FIG. 3 is an axial section of an elastic valve seat unit or cup shown inFIG. 2, illustrating the relaxed condition thereof before mounting;

FIG. 4 is an inner or bottom end view of the valve body or cup shown inFIG. 3

FIG. 5 is a perspective view graphically illustrating manipulativecollapse of the sampling tube shown in FIG. 1 and the attendantexpulsion of the gaseous fluid or sterilized air in its chamber;

. FIG. 6 is an enlarged sectional view taken substarn tially on line 6-6of FIG. 2, illustrating a valving action shown in FIG. 5 which permitsexpulsion of the contained gaseous fluid; 7

FIG. 7 is a perspective view of the body-fluid sampling tube illustratedin FIG. 5 after collapse thereof for substantial evacuation of itschamber and closing of its valves, readied for the taking of a sample ofbody fluid by suction to be performed by the collapsed chamber;

FIG, 8 is another perspective view of the collapsed body-fluid samplingtube illustrated in FIG. 7, with parts of the closure structure brokenaway and in section, depicting connection thereof to a patients vein, byconven tional suction tubing of a blood donor set, with the valvedclosure in its valve-closing position;

Phil. 9 is another perspective view of the structure shown in FIG. 8,with parts broken away and in section, showing the valved closuremanipulated to valve-open position and showing, as a consequence, asample of blood being sucked into the chamber;

FIG. 10 is an enlarged axial sectional of the closure end of thesampling tube shown in FIG. 9, similar to FIG. 2, and illustrating theaction of taking a blood sample therewith;

FIG. 11 is an enlarged side view, with parts broken away and in section,of the same closure end of the sampling tube illustrated in PEG. 10,showing the parts in V ward of the valve.

taking of a blood sample with different suction tubing equipment; I

FIG. 13 is a view similar to FIG. 12, illustrating the closure in itsvalveclosed position with the suction tubing protective cover cap on thetip end of the closure stem;

FIG. 16 is'an enlarged sectional view of the head end of a sampling tubesimilar to that illustrated in FIGS. 1 to 15 incl., with parts brokenaway, illustrating another embodiment of the valving equipment thereofand depicting in dotted lines another method of communicating thesuction chamber with suction tubing;

FIG. 17 is a sectional view with parts broken away, of a variation ofthe closure and valving structure of FIG. 16;

FIG. 18 is a sectional view, with parts broken away, of the head end ofanother embodiment of the collapsible sampling tubes illustrated inFIGS. 1 to 17 incl.;

FIG. 19 is a sectional view taken. substantially on line 19-19 of FIG.18; a

FIG. 20 is an axial section of the head end of a modified form of thecollapsible sampling tube illustrated in FIG. 2, showing in sideelevation a different type of valving closure associated therewith;

FIG. 21 is a view similar to FIG. 20, with parts broken away, showing amodified form of the valving closure thereof; 1

FIG. 22 is a sectional view similar to FIG. 20 of a further modificationof the valving closure and head end of the collapsible sampling tube,showing parts of the closure brokenaway and'in section and illustratingit in valveopen position; and I FIG. 23 is a sectional view takensubstantially on line 23-23 of FIG. 22 and showing valve parts in theirvalve closed positions.

Referring to the drawings, in which like numerals identify similar partsthroughout, it will be seen that the ii- ;lustrated embodiments of thepresent'body-fiuid sampling .tube invention comprise, in combinatiomthefollowing 'associatedelements and parts. -These include aireceptaclehaving a suction chamber and a tubular end defining an inlet passagecommunicating with the chamber. A closure is rotatably mounted to thistubular end andhas a through passage for supply 'ofbody-fluid, such asblood,

to' the inlet passage. The; closure includes a valve which of thesuction chamber or the closure, and a cooperating open. vided with asubstantially cylindrical, flexible, elastic side 7 wall section 2provided with a head end 3, preferably 1 ble tube '1 of the presentinvention preferably is molded from substantially transparent polythenewith its back end The collapsible plastic tube 1 preferably is promoldedintegral therewith, and with its initially open back end 4 closedbypinching and sealing the opposite sides together, so as to form acollapsible receptacle or container having a closed internal chamber 5.

The head end 3' is in the form of a tubular end which is preferablyprovided as an integral,externally-threaded,

, tubular neck 6 connected to the container proper by an annularshoulder 7 and having a through bore 8 serving as an inlet passagecommunicating with the suction chamber 5. The tubular neck 6 terminatesin a circular lip 9 with the neck bore 8 equipped with an annular,internal, constricting bead lb. The external threading of the neck 6may, if desired, be limited to the root section thereof, such as isillustrated by threads 11.

The head end 3 of the container or receptacle 1 of the FIGS. 1 to 15inclv embodiment is provided with valving mechanism which includes anelastic cylindrical cup 12 having an annular lip 13 at its outer endand, as will be best understood from FIGS. 2 and 3, a closing transversewall 14 at its inner end and an intervening side wall 15 7 togetherdefining a cylindrical well 16. The side wall movable valve element iscarried by the other of these two parts with the valve elementcooperatively engaging the valve seat in afl'ow blocking relation in onerotational position of the closure. In another rotational position ofthe closure the valve element is located in flow permitting relationwith respeot to the valve seat. Fluid-tight sealing means are interposedbetween the tubular end of inward thereof in open and closed positionsof the valve while permitting free rotation of-the closure relative tothe tubular end of the receptacle. 7 rt will be seen from FIGS. '1 to 15incl. that an embodi- 'ment of the present invention may be inthe formof a flexible, elastic collapsible tube or tubular receptacle 1,

preferably formed, of light-transmitting material to allow a personreadily to see into the chamber thereof, such as a polyethylenecomposition. -The' elastic plastic collapsithreaded engagement of theclosure cap skirt 23. upon I the externally-threaded container neck '6permits relative 15 of the valve body or cup 12 is' provided externallywith an'annular groove 17. The valve body 12 may be molded from anysuitable elastic material, such as natural or synthetic rubber, and thusit may. be inserted or forced snugly into the neck bore 8 to theposition illustrated in FIG. 2 with theannular internal neck bead 10snapped into the annular groove 17 and with the cup lip 13 lapping overthe transverse neck lip 9. The clos-' ing transverse wall 14 at theinner end of the valve cup 12 has an outward side or face 18 within thewell 16 which defines a valve seat, and a plurality of porting openings19, such as a diametrically located pair thereof, extend throughthis'transverse bottom wall. Thus,

the interior of the well 16 is communicated with' the A closure 21 isprovided in the FIGS. :1 to 15. incl;

embodiment which is in'the form of a cap having a transverse end wall 22and an internally-threaded skirt 23 depending therefrom and threadablyengaged on'the externally'threaded neck 6. The inside transverse face 24can be snugly enga'ged against the outer transverse end 13 of the valvecup 12 when the closure cap 21 is threaded to an inward position,illustrated in'FIG. 2, so as to provide a gasketing seal therebetween. Y

. The closure or cap 21 is provided with an inwardlyextending extension25, preferably in the form of a tubular stcm c'oa xially arranged in theskirt 23 and. depend- -ing from theyend wall 24 of'the latter. As willbe seen" from- FIG. 2, the innerend 26 in the tubular stem 25 engages ormakes valveclosing contact with the outward side 13 of'the transverseend wall 14 of the valve cup 12v in an annular zone to bridge overfandclose the mouths of the porting openings 19, so that this outward faceof the transverse bottom wall of the cup serves as a valve seat and theinner end of this tubular stem serves as the cooperating valve elementabutted together in fluid-tight engagement when the closure cap 21 is inits inward'valve-closing position illustrated in FIG. 2. The

rotation and accompanying axial translation of the former relative tothe latter between-the inward valve-closing position illustrated in FIG.2 and an outer valve-open position, such as that illustrated in FIG. 10.

The tubular valve stem 25 has a longitudinal bore 27 extending throughthe cap end wall 22 to serve as a flow passage for supply of body fluidthcrethrough to the suction chamber 5, with the inner end of this borebeing closed in the valve-closing position by an outwardly-extending,elastic nib 28 made integral with the transverse end wall 14 of thevalve cup 12 and coaxially arranged on the outward face 18 thereof. Forthis purpose, the root of the elastic nib 28 preferably is of an OD.slightly larger than the ID. of the valve stem bore 27 so as to bejammed therein in fluid-tight manner, with its outer end being taperedor rounded to facilitate lead of the nib into the stem bore.Consequently, inner valve structure of the closure described may embodya valve in the form of ported seat 18 in the valve cup 12 and acooperating valve element 26 in the form of the inner end of theclosure-carried tubular stem 25, as well as a supplemental valveincluding a seat in the form of an annular zone of the cylindrical wallof the stem bore 27 at the inner end of this tubular stern and acooperating valve element in the form of elastic nib 28 insertedtherein. Thus, the first valve has its seat carried by the valve cup 12,and the cooperating valve element is carried by the closure 21 whileconversely the second valve has its seat provided on the closure and itscooperating valve element carried by the valve cup.

The tubular stem 25 which is carried by the closure cap 21 has an outerdiameter about equal to or slightly larger than the internal diameter ofthe well 16 of the valve cup 12 when the latter is in relaxed condition,as is illustrated in FIG. 3. Thus, since the constricted bead 2th at themouth of the valve cup well 16 is of appreciably less internal diameterthe elastic material of the latter is compressed by insertion of thetubular stem 25 therethrough, as is illustrated at 299 in PEG. 2, thereto form a secure fluid-tight seal between this tubular stem and thevalve cup. The compressed elastic head 2% has wiping engagement with theexternal cylindrical surface of the tubular stem 25 in all positions or"the closure cap 21 relative to the container neck 6, as will beunderstood from a comparison of FIGS. 2 and 10. This wiping engagementbetween the compressed elastic bead and the tubular stem at and betweenthe inward valveclosing position of the closure 21 illustrated in FIG. 2and the outer valve-open position thereof illustrated in P16. 10prevents leakage of the surrounding atmosphere or air to the suctionchamber 5 when the latter is under evacuated conditions. Whiletechnically these valves may be considered separate and distinct theymay be interpreted due to their proximity and locations on the opposedbottom 14 of the valve cup 12 and the inner end 26 of tubular stem 25carried by the closure 21 to constitute an inner or master control valvestructure.

The closure cap structure 21 may be molded from plastic material similarto that employed in the molding of the container or receptacle 1 andthus parts thereof may have a degree of flexibility and elasticity.However, the tubular valve stem 25 will have sufiicient rigidity withrespect to the valve seat structure, i.e., the bottom transverse wall 14of the cup 12 and its central nib 28, as to provide the desired valvingand fluid sealing action. It is to be understood that the closure capstructure 21 may be molded from plastic material of substantialrigidity, such as polystyrene.

The closure cap 21 has its transverse top wall 22 provided coaxiallywith an outwardly-extending, tubular neck 2% having a through borecommunicated with and preferably aligned with the bore 27 of the tubularstem 25, so that these communicated bores serve as a flow passageextending through the closure. Preferably the tubular neck 29 of theclosure cap 2-]; is externally tapered to permit it to be jammed with atight fit into the sockets of cooperating parts, such as connectingelements of bodyfluid feed or suction tubing, suitable cap structure ora socketing hub of a cannula, as will be more fully explainedhereinafter. The tubular neck 29 of the closure 21 has a tip end 31which may be best seen from FIGS. 1 and 13.

A supplemental outer valve may be provided as a cover cap 32 of elasticmaterial, which may be molded from any suitable elastic material, suchas natural or synthetic rubber. The cover cap 32 has a needle-pierceableend wall 33 defined on the inner side by a face 34 opposed to and spacedfrom the tip 31 of the tubular neck 29 to provide an intervening space.The cap 32 includes an annular skirt 35 which is snugly engaged aboutthe tapered tubular neck 29 so as securely to close the neck bore 30. Aswill be best understood from FIG. 6, if the cover cap skirt 35 becompressed or pinched on diametrically opposite sides, such as atopposed points 36 and 37, as by gripping between ones finger and thumbas is illustrated in FIG. 5, the cover cap skirt may be distorted toprovide at diametrically located intervening or quarter pointslongitudinally-extending flow channels 33 and 39 (see FIG. 6)communicating the space between the inner face 34 and the tip 31 or thetubular neck 29 with the atmosphere. Thus, the outer closed valve isprovided by the elastic cap 32 and the tubular neck 29 over which it isjammed, as is illustrated in FIG. 2, this valve being openable bypinching the cap in the manners illustrated in FIGS. 5 and 6, bydistortion of the cap skirt 35 when pinched at diametrically oppositesides to form the intervening flow passages 33 and 39 between the neckand the skirt as an outlet for the closure through passage constitutedby communicated bores 27 and 3t In typical operation of the embodimentof the bodyfluid sampling tube illustrated in FIGS. 1 to 15 incl. let itbe assumed that it is to be employed for the taking of a sample of theblood of a patient. The sampling tube l. will have its chamber 5collapsed, such as in the manner illustrated in FIG. 5, with the inneror master control valve open as is attained by rotary retraction of theclosure cap 21 to the valve-open position illustrated therein and inFIG. 10. Gaseous iluid, such as sterile air, contained in the chamber 5will be expelled out through the tubular neck 2% and past the cover cap32 by way of the relief channels 33 and 39 by the pinching procedureillustrated in FIG. 5. The operator will then release his grip upon thecover cap 3?. so as to close the outer valve, thereby blocking the flowpassage extending through the closure cap 21. The operator will thenscrew the closure cap 2?. inward to the valve-closing position of FIG.2. When the receptacle or container 1 is released the recoverycharacteristic of the plastic material employed in the formation of itswalls 2 will cause it to straighten out with the side walls of thechamber 5 collapsed, to produce the prepared substantially evacuatedsampling tube illustrated in F168. 7 and 8. This preparatory evacuatingoperation may be performed an appreciable time before the collapsedsampling tube 1 is to be employed in taking a blood sample.

For the purpose of taking a blood sample conventional feeding or suctiontubing, such as that illustrated at 40 in FIGS. 8 and 9, may beemployed. Such suction tubing may be equipped at opposite ends withsingle-ended needles or cannulas 41 and 42 with the first thrust intothe patients flesh, diagrammatically illustrated at 43 in FIGS. 8 and 9,to communicate its bore and the passage of the tubing dd with a vein 44,also diagrammatically illustrated in FIGS. 8 and 9. When it is desiredto take a blood sample with the use of the collapsed sampling tube 1illustrated in FIG. 7, the tip 45 of the needle 42 may be thrust downthrough the end wall 33 of the cover cap 32 and inserted into thethrough passage of the closure cap 2.1 formed by the communicated bores27 and 36, such as substantially to the position illustrated in FIGS. 8and 10. When the operator then backs oil the closure cap 21 byrotational unscrewing, such as to the position of FIG. 10, the inner ormaster control valve will be'open as therein shown, so that blood willbe sucked from the vein 44 successively through the needle 41, thetubing 49, the needle 42, the bore 27, the well 16, the valve ports 19,the neck bore a, and into the sampling tube chamber to collect a'pool 46of blood in the latter, as is illustrated in FIGS. 9 and 10. The openingof the inner or master control valve by the backing oif or retraction oftheclosure cap 21 permits the elastic recovery of the sampling tubesidewalls 2 to expand or separate substantially to their original moldedforms, thereby creating the suction necessary to draw the blood sample46 into the sampling tube chamber 5.

Thereafter, the operator will screw the closure cap 21 down to thevalve-closing position of FIGS. 2 and 11 and Withdraw the needle 42 fromthe end wall 33 of the cover cap 32. As a result, the slit 47 formed inthe end of the cover cap 32 by the thrust of the needle 42 therethroughwill close by elastic recovery and the filled sampling tube 1 will besecurely sealed both at the inner or master control valve and at thecover cap. The cover cap serves not only as an outer valve, but alsoprotects the flow passage through the closure 21 from contaminationuntil such time as analysis procedure is performed.

If theanalysis is to require substantially all of the contents 46 of thesampling tube chamber 5 it may be removed or expelled either bydismounting the closure cap 211m by cutting off a corner of thebottomend seal 4 and then squeezing or flattening the side walls 2 of thesampling tube. apply some of the blood sample 46 as smears to slides formicroscopic examination or to produce a plurality of small examinationpools, this may be accomplished by retracting the closure 21 torthevalve-open position of .FIG. and removing the cover cap 32 to permitsmear- In the event that it is desired to mg flower. discharge bysqueezing of successive quantitles of the blood sample contained in thechamber 5 through the closure flow passage constituted by communicatedbores 27 and 30. 7

Certain treatment technique may require the taking successively of aplurality of blood samples and for this purpose the suction tubing 4%)may remain in mounted position with the bore of the needle 41 maintainedin communication with the vein 44. The successive samples will be takenwith the use of a plurality of the collapsed I sampling tubes of FIG. 7,each being handled in the manner proposed in FIGS 8, 9 and 10. Suchprocedure may be facilitated by employing a simpler type of suctiontubing which has less tendency to detach from a patients body duringrestless movement than the lengthy suction tubing 40 and equipment ofFIGS. 8 and 9. For

example, a relatively short section 149 of tubing maybe equipped withneedle 41 communicated to a patients vein 44, as is illustrated in FIGS.12 and 13, with the opposite end of the tubing being connected to ahollow socketing hub 43 fitted'in a fluid-tight manner over the taperedThe suction tubing 140 may be provided with a conventional pinch clamp49 which, when in the full line position of FIG. 12, does not restrictflow through the passage of the tubing, but when moved forward to thedotted line. position 149 will pinch off the tubing and close itspassage. Thus, when such simplified suction tubing equipment is leftattached to the patients body, as is illustrated inFlG. 13,. blooddrippage therefrom is prey'ented by the pinch clamp 49. "Successiveblood samples may then neck 29 of each securely socketed and jammed intothe hollow hub'48 and the closure cap 21 thereof manipulated tothevalve-open position to take the sample. After each sampling tube isfilled in this manner, the closure cap 21 is then screwed inward to itsvalve-closing position,

as 'is illustrated in FIG. 13, before disconnection of the tubular neckwfrom the suction tubing hub 48. Each filled sampling tube 1 may then beprotectively closed by applyinga cover cap, such as that illustrated at32,

to the tubular neck 29 thereof, as is illustrated in FIG. 15

The suction equipment, which may be desirably left attached to apatients body with its needle continuously communicated with a vein 44,may be'in another form, such as that illustrated in FIG. 14. The needle141 constitutes a cannula having an inner stub end Stl'circumscribed bya socketing hub 51 provided with a neck 52 swaged about the cannula. Thehub 51 may have a tapered socket 53 into which'the tapered tubular neck12% may be jammed for fluid-tight connection. The neck bore 131 may beprovided with a constriction in the form of an internal annular bead 54of an ID. less than the OD. of the cannula stub 51), so that when thelatter is inserted therethrough, as is illustrated in FIG. 14, afluidtight seal will be assured.

Certain practices may dictate a desire to thrust the second needle ofsuction tubing equipment of the type illustrated in FIGS. 8 and 9completely down through the valve closure of each sampling tube 1. Inthis case the tip of needle 42 may be thrust completely through thecommunicated bores 3t) and 27 to push the nib 28 out of the latter withinward'fiexure of the transverse valve cup'wall 14, and then on downthrough the latter, such as adjacent to or at one of the ports 19 (whenthis transverse walliis sufficiently distorted), for directcommunication to the evacuated chamber 5. Such practice may befacilitated by modified forms of the elastic valve cup and the closurecap, such as those illustrated in FIGS.

closing position of closure cap 121 for sealing oil the iiowpassagethrough the closure constituted by communicated bores 127 and,239.

The porting openings 119 may bcaprov'ided in an annular zone about thevalve seat socket 55, i.e., located to communicate with the well 116 atthe annular, shoulder 118. V

In the FIG. 16 embodiment the inner orimaster control valve includesseat structure provided by the face of the bottom diaphragm se and thecylindrical socket side wall 55, with the former contacted in an annularzone by the transverse inner end face 126 of the. valve stem 125 and thelatter contacted'by' an annular zone of the I cylindrical outer' surfaceof the inner end section 225 of this valve' stem. When the closure cap121 is retracted by rotary unscrewing thereof the inner end section 225which is socketed in the valve seat socket will be withdrawn from thelatter to beyond the shoulder 11% to com- Inunrcate the bore 127 withthe porting openings 119. In order to minimize the aniount ofblood whichmaybe I trapped in such a valved closure'when the'closure cap 121 isthen screwed forward to the valve-closing position of FIGJ16, the socketmay be provided in quite shallow depth whilerretaining the desiredfeature of contact be- .be taken when desired by consecutivelyconnecting sarn plingtubes 1 to the suction tubing 141), with thetubularf tween the cylindrical side wall'55 of the socket and an annularzone of the inner end section 225 of the valve stem. r i l It will beunderstood' from FIG. 16 that the structure of suchan embodimentpermitssuction tubing equip-. n ent, such as 41?, to be communicated tothe suction chamber of the sampling tube 1tltl by thrust of the tip 145'of the needle 42 completely' down through the communicated bores 239and 127 and. the .pierceable dia phragm 56, tothe dotted line positionillustrated'therein,

' v The slit, indicated indotted lines at 57 in FIG. 16, which a ispierced through the diaphragm 56 by the needle'inner end l lfiwillcloseby elastic recovery when the needle is withdrawn, so that the inner ormaster control valve will effectively seal oil the blood sample in thesampling tube chamber 135. The valve cup 112 has the mouth of its well116 provided with a constricted internal annular bead 121} to havecontinued wiping engagement with the cylindrical outer surface of thevalve stem125 in all mounted positions of the closure cap 121, which isthe full equivalent of the fluid-tight sealing means outward of theinner or master control valve of the FIGS. 1 to incl. embodiment andprovided therein by the internal bead 21 It will be noted from FIG. 16that an annular space is provided between the cylindrical side wall ofthe valve cup well 116 and the cylindrical outer surface of the valvestem 125, in which a small quantity of blood or sampled body-fluid maybe trapped. If this is considered undesirable the structure of FIG. 16may be slightly modified, such as in the manner of FIG. 17, to providethe tubular valve stem 325 with an OD. substantially equal to orslightly greater than the ID. of the intermediate main section of thevalve cup well 216, so as substantially to fill it. The fluid-sealingmeans will be embodied in this structure by the internal annular bead120 which will be stretched for localized compression, as is indicatedat 1201) in FIG. 17, by the insertion therethrough of this larger valvestem 325. The inner end of the valve stem 325 will he stepped to providea tip section 425 which is complementary in shape to the socket 55 forsnug seating therein in the valve-closing position of the closure cap121. As is indicated in dotted lines at 58 in FIG. 1'7, the socket 55may be frusto-conical in shape, and the end section 425 of the tubularvalve stem 325 shaped complementary thereto so as to minimize tendencyfor entrapment of fluid. The attendant appreciable thickness of thetransverse bottom wall 114 radially of the central diaphragm 56 oppositethe passage bore 227 assures secure sealing of an extended annular zoneof the inner end of the valve stem 325 to the opposed valve seat ofcomplementary shape while assuring the provision of the pierceablediaphragm 56 in relatively thin section for ready puncture by a cannulawhen thrust down through the bores 236 and 227.

The FIG. 16 structure may be further modified by omitting theinternally-threaded skirt of the closure 121, so that the transversehead Wall thereof extends laterally as a circular flange. This furthermodification is proposed in FIG. 17 wherein it is shown that the skirtof the closure 221 is omitted to convert the transverse head wall into acircular lateral flange 222. This valving closure is then supplementedby a separate cap member 232 which covers the entire valving closure ina protective manner and with its skirt 223 being internallythreaded forthreaded engagement with the external threads on the container neck 196.This converts the valve to a longitudinal sliding construction ratherthan a rotary one, for axial translation between the inward valveclosing position and the outward valve open position. Thus, with thecover cap 232 screwed inward to the position illustrated in FIG. 17 theinner face 234 of the top or end wall 233 of the cover cap 232 jamstightly against the tip end 231 of the projecting neck 229 to hold thebottom end 425 of the valve stem 325, serving as the valve element,snugly within the socket 55 which serves as the valve seat, in the valveclosing position there illustrated. When the cap 232 is unscrewed andremoved from the neck 106 the valve of the FIG. 17 construction may beopened by manual engagement of the circular flange 222 and applicationof pull thereon to withdraw the bottom end of the valve stem 425 fromout of the socket 55, thereby effecting communication between theclosure bores 23%) and 227 with the valve ports 119 by way of the spacebetween the walls of the socket and the bottom end of the valve stem.This axial translation of the valving closure 221 and axial returnthrust thereof thus elfect the operation of the valve. Captive means maybe provided between the valve stem 325 and the elastic valve cup 112, tolimit axial translation of the former through the constricted mouth orinternal bead 129 of the well 216. For example, the CD. of the valvestem 325 may be reduced in its root section to a diameter similar to theroot section of the valve stem 125 of the FIG. 16 structure, so that theinner valving end 425 is in the form of an enlarged head which limitsaxial translation through the internal bead 120, and this reduced 0.1).section should be at least long enough to raise the resulting enlargedvalving head or inner end 425 completely out of the socket 55 in a valveopen position. Such means for limiting the axial translation of thevalve stem 325 in the well 216 may be an annular external bead on thevalve stem, when the latter is of an OD. similar to that of the valvestem 125 of FIG. 16, located a short distance above the shoulder 118, sothat this head will jam up against the internal annular bead 120 ofvalve cup 112 during retraction. This axial travel of valve stem 325further may be limited by an annular groove 169 therein, in the vicinityof its inner head end 425 (that may be in a form similar to annulargroove 69 in valve stem 625 of the FIG. 22 embodiment), so that as thevalve stem is retracted to a valve open position the internalconstricting bead 120 in the mouth of the well 216 will snap thereintoto stop the outward travel. The internal constricting head, which isshown in its compressed condition at 1200 in FIG. 17, thus provides thefluid-tight seal for the valve stem 325 in all axial positions of thelatter, while also serving, in cooperation with annular groove 169, asretraction limit ing stop means. In these variations the closure 221 istranslated axially by sliding motion without necessitating accompanyingrotary motion after the cover cap 232 is removed.

The valved closures of FIGS. 1 to 17 incl. are well adapted to mountingin the mouths of evacuated rigid glass tube types of samplingcontainers, many of which resemble glass test tubes. The edge of theopen end or the lip of the mouth may be turned inwardly to provide aninternal annular bead or flange to constitute the equivalent of theinternal annular bead 19 of FIGS. 2 and 10 or that at of FIGS. 16 and17, to be located in the annular grooves 17 or 117 of the elastic valvecup members 12 or 112, with the latter inserted in the bore of the tube.The skirt 23 of the closure cap 21 may be of an ID. suificient totelescope over the outer side of the end of the glass tube or omittedentirely, or the glass tube may be provided in any suitable manner withexternal threads to be engaged by the internal threads in the cap skirt.

In the embodiment illustrated in FIGS. 18 and 19, the sampling tube 369,having flexible and elastic side walls 302 to define suction chamber365, is provided with a coaxially-extending tubular neck 3% which maycarry external threads preferably located on the root section 311thereof. Beyond the threaded neck section 311, the neck 3196 may beprovided with a cylindrical section 61) terminating in a transverse wall314 to close off neck bore 308. The neck section 6t) may have an annulargroove 61 provided therein in which seats a fluid-tight sealing gasket62 which may be in the form of an O-ring of elastic material, such asrubber.

Closure cap 321 of the FEGS. 18 and 19 embodiment has a Skirt 323provided with an internally-threaded section to be threadably engaged onthe threaded neck section 311, and a cylindrical section as opposed tothe cylindrical neck section 69 for wiping contact by the O-ring 62 inall mounted positions of the closure cap.

Transverse end or top Wall 322 of the closure cap 321 is provided with atubular neck 329 having a longitudinally-extending bore 33% providedwith a counterbore socket 64 at its inner end. The transverse end wall31-?- at the tip of the neck 3136 is to serve as a valve seat action ofthe FIG. 21 embodiment is the same and thus it isprovided wall 322 makessecure contact with the transverse neck wall 314 in an annular zoneradially outward of they porting openings 319 to serve as a valve. Thetransverse neck wall 314 is provided centrally with anoutweirdly-extending, tapered nib 65, preferably of elastic material,such as by being made. integral with the neck 3596 and sampling tubeside walls 302 molded from elastic plastic material. The elastic nib 65has a transverse cross-section of a diameter slightly greater than theID. of the mouth of the counterbore 64, so that the former will jam intothe latter in the valve-closing position of the closure ca 321 toprovide a second inner valving seal.

In the embodiment of FIG. 20 the sampling tube 469 is provided withelastic side walls 492 to define a suction chamber 4&5 closed ofi at thefront end by a transverse circular wall 414, preferably made integraltherewith, these parts preferably being molded from elastic plasticmaterial. A tubular neck 406 extends coaxially from the transverse endwall 414 and the bore thereof has a cylindrical section 498v adjacentthis crosswall while.

being'provided with an internally-threaded section 411 therebeyond.Since the transverse crosswall 414 is to relatively high duromet'errubber. The elasticity of the neck 6% and its annular internal rib 68permits" the necessary stretching to allow the insertion of the closureplug 625 to the seated position of FIG. 22.

When the closure plug 625 of the FIGS. 22 and 23 embodiment is inthe'relative rotary position of FIG. 22, the radial notch 67communicates the inner end 6-27 of the through passage 436 with the portor opening 419 for flow connection to the suction chamber 4&5. When therotary closure plug'625 is rotated to another radial position, such asthat illustrated in FIG. 23, wherein the As will be understood from FIG.22, an additional sealing gasket may be inserted in the embodiments ofFIGS. 20 to 23 incl., in the form of an annular ring '70 interposedbetween the head 621 (or heads 421 and 521 of FIGS. 20 and 21) and theouterend of the tubular neck,

so that it will be jammed therebetween in fluid-tight sealing engagementin the valve-closing positions of the closures.

serve as a valve seat it is suitably ported, such as by a of the neck466. The closure plug 425 has its inner end,

provided in the form of a cylindrical section in the'external surface ofwhich is formed an annular groove 161 in which is seated an O-ringgasket having wiping contact with the opposed inner surface of thecylindrical neck The closure plug 425 carries a tubular'neck 429 havinga through bore 43% ntending to the inner end 4260f the closure plug,with the inner end or month 427 thereof v opposed to an imperforatcportion of the container. crosswall 414. Thus, the inner stem end 426serves as .a valve element which will have sealing engagement with thecrosswall 414 serving as a valveseat. When the closure plug 425 isretracted communication willbe established between the inner end- 427 ofthe bore or How passage 430 and the offset port 419, for communicationto the suction chamber 405. I

In the FIG. 21 embodiment many of the parts are 2 similar to those ofthe FIG. 20 embodiment except that the fluid-tight sealing means, in aform including O-ring 162 that is seated'in an annular groove 262 formedon the inner face oi the cylindrical section 508 of the neck bore. TheO-ring gasket 162 has wiping contact with cylindrical section 525 of theclosure plug in all mounted positions of the closure 521 carrying thelatter. Valving as that or" the FIG. 20 embodiment.

' section 408 in all mounted positions of'the closure plug. 7

In the embodiment of FIGS. 22 and 2 3 which is similar in many respectsto those of FIGS. 20 and 21, the closure 621 has the inner end 627 ofits through bore communicated to a'transversely-extending, radial notch67 in the finner end 626 of the closure plug 625. The neck bore 668 isprovided with'an annular internal rib 68 which issnugly seated in. afluid-tight manner in an annular groove 69 formed in the closure plug625, there 7 to provide afluid-tight seal in all rotary p'o'sitions ofthe closure Plug. Elastic plastic'material may be employed for molding,thegsampling tube 400,.including it side i.

walls 492 and the coaxially-ex'tending tubular neck fifi, so that theannular rib 68 when madeintegral there-1' with will be elasticfor snuglyengaging into the'annular plug groove 69 to forrn a secure fluid-tightseal. This fluid-tight seal may be enhanced by also forming the closureplug from similar elastic plastic mater-ialgor,

It will thus be seen that the objects set forth above,,

among those made apparent fromthc preceding description, are eflicientlyattained and, since certain changes may be made in the aboveconstructions without departing from the scope of the invention, it isintended that all matter contained in the above description or shown inthe accompanying drawings shall be interpreted as illustrative and notin a limiting'sense.

It is also to be understood that the following claims are intended'tocover all of the generic and specific features of the invention hereindescribed, and all statements or" the scope of the invention which, as amatter of language, might be saidto fall therebetween.

Having described my invention, what I claim as new and desire to secureby Letters Patent is: I

1. A body-fluid sampling tube comprising, in combination, V

(a) a receptacle having a suction chamber evacuated to a relatively highdegree of evacuation sufiicient to suck thereinto body fluid from acavity in and the circulatory system of a persons body when communicatedthereto, (b) said receptacle havinga tubular end defining a suctioninlet passage communicating with the chamber .for this purpose, i (c)closure means movably mounted to said tubular end for axial translationrelative thereto and having a centrallthrough longitudinal passage forsupply of body-fluid to the inletpassage,

1 (d) said receptacle tubular end and closure means having a pair oftelescoped tubular parts respectively connected in fluid-tight mannerthereto with one of said parts mounted in the other for relative axialtranslation between inward relative valve-closing positions and outwardrelative valve-open positions,

(e) said telescoped tubular parts carrying at the inner 7 end of theclosure supply passage complementary valve structures cooperativelyengaged in flow blocking relation to form a closed valve in the inwardvalve-closing axial position of one of saidtelescoped tubular partsrelative tor the other preventing leak-f age of atmospheric air to said,evacuated suction chamber through the closure 'supply passage and. Iaxially separable in flow permitting relation when one of saidtelescopedtubular parts isretracted to its outward valve-open positionrelative to the other relatively high elasticity carried by one of saidpair of telescoped tubular parts in a fixed axial location thereon andconfined after assembly of parts in distorted compressed conditionbetween said pair of telescoped parts in a relatively narrow annularzone to limit drag resistance to relative longitudinal sliding action ofsaid pair of telescoped parts, said compressed rib means being underappreciable compression of a degree sufiicient to prevent leakagetherepast of surrounding atmospheric air into the evacuated suctionchamber while body fluid is sucked into the latter through the closuresupply passage, said telescoped tubular parts being freely slidablemanually relative to each other at all points of opposition axiallyotlset from the location or" said compressed rib means, and

(g) manually manipulative carnming means temporarily locking said pairof telescoped tubular parts in their relative valve-closing positionsand to permit release for relative retraction to their valve-openpositions.

2. The body-fluid sampling tube as defined in claim 1 in which saidsuction chamber of said receptacle initially is in expanded form andfilled with air, said chamber being partly defined by movable receptaclestructure for inward movement to reduce the chamber capacity and expeltherefrom air therein through said valve in its open position forattaining the evacuated condition, said closure having an exteriortubular neck terminating in a tip end section through which the supplypassage extends, and a supply passage valving cover cap of materialhaving appreciable elasticity including an integral relatively thin andreadily needle-pierceable closed end wall through which a hollow needlemay be easily thrust by hand and an integral pinch-distortable circularsidewall together defining a socket that initially when unmounted is ofsmaller transverse dimensions than those of said tip end section, saidtip end section being jammed into the socket of said cover cap withstretch of the sidewall of the latter for closing oft" the supplypassage in a fluid-tight manner, the cap sidewall being capable of beingseparated from said tip end section along at least one longitudinal lineof mutual contact to define a flow channel leading from the supplypassage to the surrounding atmosphere when said cap sidewall is pinchedlaterally against said tip end section for allowing evacuating expulsionof air from said chamber.

3. A body-fluid sampling tube comprising,

combination,

(a) an elongated, manually collapsible, tubular container of flexibleand foldable plastic capable of self recovery from distorted shapesealed at one end and having a valve closure at the other end defining asuction chamber capable of evacuation with opening of the valve closureand manual collapse of said container;

(12) the valve closure-equipped end having an externally-threaded,tubular neck terminating in a circular lip (c) with the bore of the neckequipped with an annular, internal, constricting bead;

(d) an elastic cylindrical cup having an annular lip as its outer end, aclosing transverse wall at its inner end and an intervening cylindricalside wall together defining a cylindrical well,

(2) said side wall being provided externally with an annular groove inwhich said annular bead is seated with said cup inserted snugly into theneck bore and the cup lip lapping said neck lip;

(f) the outward side of said transverse end wall of said cup within thewell defining a valve seat having at least one porting opening;

3) a closure cap having a transverse end wall and an internally-threadedskirt depending therefrom and threadably engaged on said neck, saidclosure cap i i being capable of axial translation between an inwardvalve-closing position and an outerposition upon rotation;

(h) a tubular stem coaxially arranged in the skirt of said closure capand extending inward from the end wall of the latter, said stem beingtranslatable axially between an inward valve-closing position and anouter valve-open position,

(i) said stem having a longitudinal through bore to serve as a flowpassage for supply of body fluid therethrough to the suction chamber,

(j) the inner end orsaid stem serving as a valve element which makesvalve-closing contact with said valve seat in an annular zone when saidstem is in its inward valve-closing position to constitute the valveclosing off communication between the porting opening and the stem bore;and

(k) annular fluid-tight sealing means located between the well sidewalland said stem fixedly carried by one thereof at a fixed location on thelatter outward of said complementary valve element and seat andmaintaining wiping engagement with the other in all longitudinalpositions of said stem at and between the inward valve-closing and outervalve-open positions of the latter, said sealing means being beforeassembly of said stem into said cup in the form of an annular elasticand transversely extending rib means and being confined in distortedcompressed condition between said well wall and said stem in arelatively narrow annular zone to limit drag resistance to relativelongitudinal sliding action of said wall and stem, said compressed ribmeans being under appreciable compression of a degree sufiicient toprevent leakage therepast of surrounding atmospheric air into theevacuated suction chamber while body fluid is sucked into the latterthrough said stern bore.

4. The body-fluid sampling tube as defined in claim 3 characterized bysaid annular, compressed fluid-tight sealing rib means being aninternal, annular, elastic bead at the mouth of the well integral withsaid cup and of an internal diameter when relaxed appreciably less thanthe external diameter of said stem and having wiping engagement with thelatter.

5. The body-fluid sampling tube as defined in claim 3 characterized bysaid closure cap having a tubular neck extending outwardly coaxiallyfrom the end wall thereof as an outer extension of said stem andterminating in a tip, said cap neck having a through bore communicatingwith the stern bore together serving as a body-fluid supply passage; anda supply passage-blocking cover cap of elastic material having anintegral relatively thin and readily needle-pierceable closed end wallthrough which a hollow needle may be easily thrust by hand and anintegral pinchdistortable circular sidewall together defining a sockettherein in which the tip of said cap neck is engaged with stretch ofsaid cap sidewall in a fluid-tight manner with said neck tip spacedinwardly from said cover cap end wall to allow evacuating expulsion ofair from said suction chamber when said cover cap sidewall is pinched toseparate it from said neck along at least one longitudinal line ofmutual contact by there defining a flow channel communicating the neckbore with the surrounding atmosphere. 7 v

6. The body-fluid sampling tube as defined in claim 4 characterized bysaid valve seat being in the form of a coaxial socket in the outwardside of said elastic cup end V the mouth ofi-the socket and with aplurality of porting openings being provided in this annular shoulderand extending through the end wall to communicate the suction chamberwith the bore of said stem when the inner end section of the latter isretracted from the socket;

7 References Cited the Examiner UNITED STATES PATENTS 1'3 10/59 'GerardeL1 128-276 5/60 Rabb 222-525 11/61 Gronemeyer et a1 222-521 12/61Pallotta 128-218 3/63 Dipierro et a1. 222-525 "FOREIGN PATENTS 8/31Germany. v V

10 RICHARD Afl' 'GAUDE T, Primary Examiner.

, JORDAN FRANKLIN,;Examihef.

1. A BODY-FLUID SAMPLING TUBE COMPRISING, IN COMBINATION, (A) ARECEPTACLE HAVING A SUCTION CHAMBER EVACUATED TO A RELATIVELY HIGHDEGREE OF EVACUATION SUFFICIENT TO SUCK THEREINTO BODY FLUID FROM ACAVITY IN AND THE CIRCULATORY SYSTEM OF A PERSON''S BODY WHENCOMMUNICATED THERETO, (B) SAID RECEPTACLE HAVING A TUBULAR END DEFININGA SUCTION INLET PASSAGE COMMUNICATING WITH THE CHAMBER FOR THIS PURPOSE,(C) CLOSURE MEANS MOVABLY MOUNTED TO SAID TUBULAR END FOR AXIALTRANSLATION RELATIVE THERETO AND HAVING A CENTRAL THROUGH LONGITUDINALPASSAGE FOR SUPPLY OF BODY-FLUID TO THE INLET PASSAGE, (D) SAIDRECEPTACLE TUBULAR END AND CLOSURE MEANS HAVING A PAIR OF TELESCOPEDTUBULAR PARTS RESPECTIVELY CONNECTED IN FLUID-TIGHT MANNER THERETO WITHONE OF SAID PARTS MOUNTED IN THE OTHER FOR RELATIVE AXIAL TRANSLATIONBETWEEN INWARD RELATIVE VALVE-CLOSING POSITIONS AND OUTWARD RELATIVEVALVE-OPEN POSITIONS, (E) SAID TELESCOPED TUBULAR PARTS CARRYING AT THEINNER END OF THE CLOSURE SUPPLY PASSAGE COMPLEMENTARY VALVE STRUCTURESCOOPERATIVELY ENGAGED IN FLOW BLOCKING RELATION TO FORM A CLOSED VALVEIN THE INWARD VALVE-CLOSING AXIAL POSITION OF ONE OF SAID TELESCOPEDTUBULAR PARTS RELATIVE TO THE OTHER PREVENTING LEAKAGE OF ATMOSPHERICAIR TO SAID EVACUATED SUCTION CHAMBER THROUGH THE CLOSURE SUPPLY PASSAGEAND AXIALLY SEPARABLE IN FLOW PERMITTING RELATION WHEN ONE OF SAIDTELESCOPED TUBULAR PARTS IS RETRACTED TO ITS OUTWARD VALVE-OPEN POSITIONRELATIVE TO THE OTHER TO APPLY SUCTION TO THE CLOSURE SUPPLY PASSAGE.(F) FLUID-TIGHT SEALING MEANS INTERPOSED BETWEEN SAID PAIR OF TELESCOPEDTUBULAR PARTS AT A POINT OUTWARD OF SAID VALVE IN THE FORM BEFOREASSEMBLY OF PARTS OF AN ANNULAR TRANSVERSELY EXTENDING RIB MEANS OFRELATIVELY HIGH ELASTICITY CARRIED BY ONE OF SAID PAIR OF TELESCOPEDTUBULAR PARTS IN A FIXED AXIAL LOCATION. THEREON AND CONFINED AFTERASSEMBLY OF PARTS IN DISTORTED COMPRESSED CONDITION BETWEEN SAID PAIR OFTELESCOPED PARTS IN A RELATIVELY NARROW ANNULAR ZONE TO LIMIT DRAGRESISTANCE TO RELATIVE LONGITUDINAL SLIDING ACTION OF SAID PAIR OFTELESCOPED PARTS, SAID COMPRESSED RIB MEANS BEING UNDER APPRECIABLECOMPRESSION OF A DEGREE SUFFICIENT TO PREVENT LEAKAGE THEREPASTSURROUNDING ATMOSPHERIC AIR INTO THE EVACUATED SUCTION CHAMBER WHILEBODY FLUID IS SUCKED INTO THE LATTER THROUGH THE CLOSURE SUPPLY PASSAGE,SAID TELESCOPED TUBULAR PARTS BEING FREELY SLIDABLE MANUALLY RELATIVE TOEACH OTHER AT ALL POINTS OF OPPOSITION AXIALLY OFFSET FROM THE LOCATIONOF SAID COMPRESSED RIB MEANS, AND (G) MANUALLY MANIPULATIVE CAMMINGMEANS TEMPORARILY LOCKING SAID PAIR OF TELESCOPED TUBULAR PARTS IN THEIRRELATIVE VALVE-CLOSING POSITIONS AND TO PERMIT RELEASE FOR RELATIVERETRACTION TO THEIR VALVE-OPEN POSITIONS.